We have not planned any intervention to address the ectopic bone formation, as our patient remains asymptomatic and clinically well. BMP and i-Factor have similar mechanism of action and therefore can potentially have similar complication profile. We suspect that the serous discharge in our patient is a similar inflammatory response with i-Factor. BMP use has also shown to cause seroma formation due to exaggerated inflammatory reaction, with seroma fluid showing elevated levels of Interleukin-6 and Interleukin-8. Evidence of symptomatic ectopic bone formation including neurological impairment have been reported following use of BMP. However, this did not affect the clinical outcome and was of little clinical significance.īMP is another bone graft substitute which has been used in recent years for adult spinal surgery to augment fusion in lumbar and cervical spine. This was not true as use of i-Factor showed higher incidence of graft migration and ectopic bone formation when compared to autograft. They also state that i-Factor is not a morphogen and the signals sent following P-15 attachment in a bony site activates cells that are pre-programmed to turn into osteoblasts. The manufacturer ( states that all cellular activity due to P-15 attachment is restricted to the implant surface thereby avoids ectopic bone growth. Autograft and i-Factor have both proven to produce ectopic bone formation. After cell binding and proliferation the differentiation of cells increase TGFb-1, BMP-2 and BMP-7 influencing all processes of new bone formation. I-Factor increases the opportunity of cell binding by making an abundance of P-15 available to osteogenic cells. This was attributed to graft migration outside the cage and disc space. In a prospective study to assess efficacy of i-Factor in lumbar interbody fusion, it was observed that heterotopic ossification was noted in 48% who received i-Factor and 14% who received autograft. It facilitates ingrowth of bone by promoting the migration of mesenchymal stem cells and other progenitor cells from surrounding tissue. This induces cell proliferation, differentiation and subsequent osteogenesis. Attachment of P-15 to osteogenic cells initiates a cascade of intracellular signalling that triggers the synthesis of extracellular matrix and growth factors. P-15 amino acid is similar to the one found in type 1 collagen of bone. The biologically active component is a synthetic 15 amino acid residue which when combined with the anorganic matrix provides a scaffold for cell invasion, binding and osteogenesis.
The anorganic bone matrix is composed of calcium phosphate which provides osteoconductive properties of cell invasion and migration. I-Factor TM is a composite made of anorganic bone matrix and bioactive P-15 peptide.
There is no published literature regarding its complication profile in spinal surgery for children. The few published studies of i-Factor were on adults who had spinal surgery. There is a paucity of literature evidence to support its efficacy and safety. Peptide enhanced composite graft was granted permission in 2008 for use in Europe. However, it is associated with complications such as donor site morbidity, increased surgical time and limited supply.
Iliac crest bone grafting remains gold standard for fusion procedures. Spinal fusion is a crucial step in correction of deformity to prevent failure of metalware and progression of deformity.
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